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Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Karadeniz Technical University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
emine seda guvendag guven, Karadeniz Technical University
ClinicalTrials.gov Identifier:
NCT02202278
First received: July 23, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose
The aim of the study is to determine serum oxidative stress status by ischemia modified albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control group. We also aim to reveal the association between serum levels of these factors and oocyte quality.

Condition
Ovarian Hyperstimulation Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status

Resource links provided by NLM:


Further study details as provided by Karadeniz Technical University:

Primary Outcome Measures:
  • Change the levels of oxidative stress markers [ Time Frame: 1 day ]
    Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels


Biospecimen Retention:   Samples Without DNA
Blood of involved patients in study was drawn for study for ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels. After the study all blood samples will be destroyed according to regulations.

Estimated Enrollment: 25
Study Start Date: June 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ovarian hyperstimulation patients
Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit >45%, weight gain >2 kg, white blood cell count >15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of >50 ml/min, liver dysfunction.
without ovarian hiperstimulation
Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS

Detailed Description:
  • Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management
  • Control patients are selected from patients without signs of OHSS
  • All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation.
  • When there are at least two or three follicles >17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval.
  • Serum samples are collected on day of HCG for study and control group patients.
  • Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels.
  • This is a case control study
  • Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are administered luteal long protocol for controlled ovarian stimulation
Criteria

Inclusion Criteria:

• Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor

Exclusion Criteria:

  • known inherited or acquired thrombophilia
  • previous thromboembolism
  • previous, current or planned anti-thrombotic treatment
  • first degree relatives with known genetic thrombophilia
  • systemic diseases
  • smoking.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02202278

Contacts
Contact: emine seda guvendag guven, MD 905332339854 emineseda@yahoo.com
Contact: suleyman guven, MD 90 drsuleymanguven@yahoo.com

Locations
Turkey
T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital Recruiting
Ankara, Turkey, 06600
Contact: rafet duraker, MD    905342325333    rafetduraker@gmail.com   
Contact: yeşim bayoglu tekin, MD    05055171973    yesimbay@yahoo.com   
Sub-Investigator: Serdar Dilbaz, MD         
Sub-Investigator: Ahmet Mentese, MD         
Sub-Investigator: Sevim Aydin, MD         
Sponsors and Collaborators
Karadeniz Technical University
Investigators
Study Director: emine seda guvendag guven, MD Karadeniz Technical University
Principal Investigator: rafet duraker, MD T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
  More Information

Publications:
Responsible Party: emine seda guvendag guven, medical doctor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02202278     History of Changes
Other Study ID Numbers: 139EK1
Study First Received: July 23, 2014
Last Updated: July 24, 2014

Keywords provided by Karadeniz Technical University:
ovarian hyperstimulation
Oxidative Stress
IMA
OHSS
ICSI
long agonist protocol
TAC
TOS
OSI
MDA

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on March 23, 2017